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Pelvic mesh victims held to ransom by Labor

In a new low for Labor, Health Minister Mark Butler has sneakily attached an amendment to a bill which was designed to support pelvic mesh victims following a 2022 class action.

If successful, the additional measure gives the government unprecedented power to approve overseas substitute medicines that haven’t been through Australia’s regulatory pathway. Sounds pretty familiar, doesn’t it?

Tying this significant change to support for pelvic mesh victims in the Therapeutic Goods Amendment 2022 Measures No 1 Bill 2022 is a disgraceful act and a dangerous precedent. It must be stopped.

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TGA admits they didn’t analyse the patient data!

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The Australian TGA confirmed they NEVER analysed the patient level data from the Pfizer clinical trials.

They just took the word of Big-Pharma and assumed the American FDA had done the work. We never checked the individual patient data here in Australia.
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The Narrative continues to fall apart – TGA at Senate Estimates

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With each new day we find more evidence of conflicts of interest, lies from the supposed “experts” and none of these bureaucrats want to acknowledge it. We need a Royal Commission to bring their lies out into the daylight.

Transcript (click)

Senator ROBERTS: Can you tell me how many medicines were approved under the provisional approval pathway during the COVID period 1 July 2020 to date? My numbers are 13 vaccines and six drugs; is that correct?

Dr Skerritt: Are you talking specifically about COVID treatments and COVID vaccines?

Senator ROBERTS: No, any vaccines or drugs that have been approved using the provisional pathway.

Dr Skerritt: I will start with COVID vaccine treatments. There have been seven COVID vaccines and eight COVID treatments. I’ll just check whether I’ve got the numbers for other medicines during that period. You’re talking about the provisional approval pathway?

Senator ROBERTS: Yes.

Dr Skerritt: From 1 July this year there have been five provisional approvals. From the period 1 July 2021 to 30 June 2022 there have been 23. That would include those COVID treatments. What it does show is a lot of other medicines, such as cancer medicines, such as medicines for rare conditions, have also been approved. In the financial year 2021, from 1 July 2021 to 30 June 2022, there were five. Over the period you’re talking about, that would add up to 33.

Senator ROBERTS: How many drugs have been approved under the normal process during that same period?

Dr Skerritt: During the same period? I will add the three financial years and I’ll check my mental arithmetic. So 36 this current financial year, and 117. These are either new approvals or new indications approved. And 95 the year before. So, it is a significant percentage, but not most of them.

Senator ROBERTS: Is the maximum provisional approval period six years because it can take that long to get drugs approved under the old approval system?

Dr Skerritt: A provisional approval is only valid for two years and then the company either has to come back and show why they cannot obtain all the data within the period and apply for an extension.

Senator ROBERTS: No, the maximum provisional approval?

Dr Skerritt: They can apply for further lots of two years.

Senator ROBERTS: Is the maximum provisional approval—

Dr Skerritt: Overall the maximum period is six years, but it’s not six years off the bat.

Senator ROBERTS: It’s two years with extensions.

Dr Skerritt: They are possible extensions; they’re not guaranteed.

Senator ROBERTS: How much money do you save pharmaceutical companies by switching from full approval to express approval? I understand it’s hundreds of millions per approval?

Dr Skerritt: It actually costs the pharmaceutical companies more in regulatory fees for provisional approval.

Senator ROBERTS: No, I didn’t say regulatory fees. How much are you saving the pharmaceutical companies by giving them express or provisional approval rather than going through the six-year period for getting proper approval?

Dr Skerritt: No, you’ve misinterpreted the system. It’s not a six-year period to get full regulatory approval.

Senator ROBERTS: It varies. I accept that.

Dr Skerritt: Most of our approvals are submitted as a standard approval, especially, for example, if it wasn’t a public health emergency or it’s a drug that already has others in the same category. They’re submitted as a standard approval.

Senator ROBERTS: Dedicated trials for their drugs, I understand, can be hundreds of millions of dollars. How much time and money would they save by going express?

Dr Skerritt: We would not give a provisional approval to a medicine unless there were clinical trials.

Senator ROBERTS: How much money does it save if they do a provisional without doing a formal or normal approval process? How much money does it save the drug company?

Dr Skerritt: I don’t believe there are necessarily savings. The situation would be different for every drug. It’s really important to emphasise there were very extensive clinical trials for the vaccines and treatments that have been through provisional approval.

Senator ROBERTS: My understanding is that it can cost hundreds of millions of dollars to get the full approval process. Without the dedicated trial, they could save hundreds of millions of dollars per drug?

Dr Skerritt: I don’t necessarily agree with you.

Senator ROBERTS: When does the provisional approval for Pfizer expire?

Dr Skerritt: The two-year period will be two years from the anniversary of the first approval. I would emphasise that in certain countries—

Senator ROBERTS: What is that date?

Dr Skerritt: The products are now fully approved.

Senator ROBERTS: What is the date of provisional approval expiry?

Dr Skerritt: For the very first approval, for 16 years and over, the two-year period finishes on 25 January 2023.

Senator ROBERTS: I have in front of me a document called the Australian Public Assessment Report for Tozinameran, from Comirnaty (Pfizer), dated December 2021. Is this the approval application for the paediatric version of the Pfizer vaccine?

Dr Skerritt: No, it is not. An Australian Public Assessment Report is a summary of the assessment that we did of the application. You mentioned Pfizer. The actual application is over 220,000 thousand pages of paper from Pfizer for that particular group of vaccines.

Senator ROBERTS: I reference page 61, which states:

Limitations of the current application data. Safety follow-up is currently limited to median 2.4 months post dose 2 in cohort 1, and 2.4 weeks for the safety expansion cohort.

What is the safety expansion cohort?

Dr Skerritt: Remember, also, this was going back to the time of approval. We now have hundreds of millions, actually more than a billion, people who have been vaccinated with that vaccine and experience going on since December 2020, when the first vaccination was done. The safety expansion cohort is in a clinical trial where individuals are monitored closely and the data reported back to regulators for periods of months, leading to years, after their vaccination.

Senator ROBERTS: Did you recommend this substance based on 2.4 weeks of safety testing or did you get more in? If so, over what period? How many months?

Dr Skerritt: Remember the initial approval from TGA was based on that two months of follow-up, but we also had the experience of other countries that had more than a month before starting mass vaccination campaigns. When we approved Pfizer on 25 January2021, we were in almost daily contact with the British, who by that stage had vaccinated millions of British people by 25 January 2021. Real-world evidence played a very important role in both the approvals and in the ongoing safety monitoring of these vaccines.

Senator ROBERTS: So you relied on data from other countries and you relied for periods of months, merely months. It can’t be more than six months, because there’s a gap between application and approval and to give time for collection of data and analysis. There should be years of data before we start putting this stuff into our children, yet it’s months.

Dr Skerritt: I disagree in the context of a pandemic and a public health crisis. Regulators globally felt that it was appropriate to do initial approvals—

Senator ROBERTS: You’re the Australian regulator.

Dr Skerritt: As the head of the Australian regulator, I would do precisely the same if I had my time again. The alternative would have been to leave Australians unvaccinated through the course of 2020, 2021 and 2022, and there would have been tens of thousands more Australian deaths.

Senator ROBERTS: Can I reference a letter from the Commonwealth Department of Health and Aged Care, signed by Radha Khiani, Director, Governance and Coordination section, in which the department makes this claim. The letter from 4 November 2022, just last week, states:

A large team of technical and clinical experts at the TGA carefully evaluated the data submitted by the sponsor. A treatment or vaccine is only provisionally approved if this rigorous process is completed.

This document concerned the use of Pfizer stages 2 to 3 cynical trial data in support of their application for provisional approval. Did the TGA check the stage 2 and stage 3 clinical trial data from Pfizer? Did you check it?

Dr Skerritt: We did check the phase 2 and phase 3 clinical trial data from Pfizer and we also took it to independent external medical experts as well as consumer representatives.

Senator ROBERTS: Referencing Freedom of Information No. 2289, in which the applicant requested a copy of the stage 2 and stage 3 clinical trial data, the TGA responded that the ‘TGA does not hold any relevant documents relating to the request’. That was a request for stages 2 to 3 clinical trial data.

Dr Skerritt: Without seeing what’s in your hand, I believe that you asked for individual patient data rather than the phase 2 and phase 3 clinical trial data. I can give you my word that we assessed the phase 2 and phase 3 clinical trial data; otherwise, what else did we do? Look at the colour of the label on the bottle? That is the main thing our team of several thousand clinicians look at in reviewing a new vaccine, the phase 2 and phase 3 clinical trial data. It is the centrepiece.

Senator ROBERTS: The freedom-of-information request then asked for ‘any documents confirming the process of analysing this data to a decision, including meetings, notes, dates and times’. Again the TGA replied, ‘We have no relevant documents.’ Did you review the stage 2 and stage 3 data or not, and, if you did, why did you tell this freedom-of-information applicant you did not have these documents? Which document is the lie? One of them is.

Dr Skerritt: I don’t have that document in front of me. We can review it on notice. But we reviewed the phase 2 and phase 3 clinical trial data at length.

CHAIR: This really needs to be the last one so I can share the call.

Senator ROBERTS: I just want you to think about this and confirm it or otherwise: and ‘the trail data contained sufficient proof the vaccines were safe and effective, sufficient to meet the criteria for provisional approval’; is that correct?

Dr Skerritt: Correct. Yes.

Transcript (click)

Senator ROBERTS: I asked a question earlier, Professor Skerritt, about the number of drugs approved under the full approval process, the normal process. If you exclude the number of drugs that you said were new uses for existing drugs and medical devices, what is the figure for new drugs approved under the full approval process in the last three years?

Dr Skerritt : It will be about 90, but I’ll give you the exact answer on notice. We approve between 30 and 40 new drugs a year.

Senator ROBERTS: You also confirmed your view that ‘the trial data contained sufficient proof that the vaccines were safe and effective, sufficient to meet the criteria for provisional approval’. Yet after 18 months and analysing the data, some of the world’s leading virologists and pharmacologists from UCLA, Stamford and here in Australia found that the ‘Stage 2 and Stage 3 trial data showed the vaccine was associated with a 36 per cent increase in serious adverse events’ and ‘out of every 10,000 people injected, 18 will experience a life-threatening or altering complication, and the vaccine should not have been approved, as it caused more harm than it prevented’. That’s what they said. One of the papers—there are several papers—is titled ‘Serious adverse events of special interest following mRNA COVID-19 vaccination in randomised trials in adults’. How could ATAGI review the data and conclude that everything was fine, with the world’s leading experts on the subject, in a peer reviewed and published paper, then finding the exact opposite? Did you approve the vaccine in a deal with colleagues in the pharmaceutical industry?

Dr Skerritt : I think that’s an offensive allegation, and we certainly did not.

Senator ROBERTS: You had colleagues in the pharmaceutical industry.

Dr Skerritt : We did not approve the vaccine in a deal with colleagues in the pharmaceutical industry.

Senator ROBERTS: You had colleagues in the pharmaceutical industry.

Dr Skerritt : I wouldn’t say that they were colleagues; we work with people. We also work with—

Senator ROBERTS: That’s what I mean: you worked with them.

Dr Skerritt : people in terms of the courts, including the criminal court. So, we work with people in the pharmaceutical industry and we work with other government people, but they’re not colleagues in the sense of working for the same organisation.

Senator ROBERTS: Did you do a deal or come to an arrangement with the—

Dr Skerritt : No.

Senator ROBERTS: It could have been just provisional approval to get it through. Did you do that with the pharmaceutical industry?

Dr Skerritt : No. No, that’s an offensive and unfounded allegation, and I’d like you to withdraw it.

Senator ROBERTS: There are thousands of people who are dead, and we’ll get on to that in the next session.

Dr Skerritt : I disagree with you. There are 14 deaths associated with vaccines in Australia, all—

Senator ROBERTS: We’ll get on to that in the next Senate estimates.

Dr Skerritt : I look forward to it.

Senator ROBERTS: Yes, so do I.

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ATAGI Moderna recommendation for 6 month to 5 year olds disgraceful abandonment of precautionary principle

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The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended the Moderna jab for children aged 6 months to 5 years.[1] The vaccine only holds provisional approval. Provisional approval is given to drugs where research is still being conducted, research that might uncover adverse effects not initially apparent.[2]

The risk of death to 5 year olds from the more fatal, early variants of COVID was as low as 0.0024% or roughly 1 in 40,000.[3] This does not reflect the risk of Omicron, the dominant strain across the world right now, which is estimated to be 78% less fatal.[4] This would imply a risk of around 1 in 180,000 to 5 year olds from Omicron. On the other hand, the risk of vaccine caused myocarditis is around 1 in every 10,000 for 12-17 year old boys.[5]

There is simply not enough information on the long-term effects to decide on the risk benefit calculation like ATAGI claims to have. ATAGI has abandoned the precautionary principle in provisionally approving Moderna for use in toddlers and children when it has no longitudinal, years long research.

[1] https://www.health.gov.au/news/atagi-recommendations-on-covid-19-vaccine-use-in-children-aged-6-months-to

[2] https://www.tga.gov.au/covid-19-vaccine-information-consumers-and-health-professionals#:~:text=Sponsors%20may%20apply%20for%20full%20registration%20when%20there%20is%20more%20clinical%20data%20to%20confirm%20the%20safety%20of%20the%20vaccine

[3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext#:~:text=0018%E2%80%930%C2%B70043)-,5%20years,-0%C2%B70024%25%20(0

[4] https://www.sciencedirect.com/science/article/pii/S1201971222002284#:~:text=We%20found%20that%20the%20high%20relative%20transmissibility%20of%20the%20Omicron%20variant%20was%20mainly%20due%20to%20its%20immune%20evasion%20ability%2C%20whereas%20its%20infection%20fatality%20rate%20substantially%20decreased%20by%20approximately%2078.7%25

[5] https://www1.racgp.org.au/newsgp/clinical/vaccine-myocarditis-risk-reaches-1-in-10-000-for-a

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Moderna approval for 6 month to 5 year olds disgraceful abandonment of precautionary principle

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Update 3/8/22: ATAGI has now approved the Moderna vaccine for under 5 year olds, meaning the vaccine rollout will proceed to toddlers.

The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna jab for children aged 6 months to 5 years.[1] Provisional approval is given to drugs where research is still being conducted, research that might uncover adverse effects not initially apparent.[2]

The risk to 5 year olds from the more fatal, early variants of COVID was as low as 0.0024% or roughly 1 in 40,000.[3] This does not reflect the risk of Omicron, the dominant strain across the world right now, which is estimated to be 78% less fatal.[4] On the other hand, the risk of vaccine caused myocarditis is around 1 in every 10,000 for 12-17 year old boys.[5]

There is simply not enough information on the long-term effects to decide on the risk benefit calculation like the TGA claims to have. The TGA has abandoned the precautionary principle in provisionally approving Moderna for use in toddlers and children when it has no longitudinal, years long research.

[1] https://www.tga.gov.au/covid-19-vaccine-spikevax-elasomeran

[2] https://www.tga.gov.au/covid-19-vaccine-information-consumers-and-health-professionals#:~:text=Sponsors%20may%20apply%20for%20full%20registration%20when%20there%20is%20more%20clinical%20data%20to%20confirm%20the%20safety%20of%20the%20vaccine

[3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext#:~:text=0018%E2%80%930%C2%B70043)-,5%20years,-0%C2%B70024%25%20(0

[4] https://www.sciencedirect.com/science/article/pii/S1201971222002284#:~:text=We%20found%20that%20the%20high%20relative%20transmissibility%20of%20the%20Omicron%20variant%20was%20mainly%20due%20to%20its%20immune%20evasion%20ability%2C%20whereas%20its%20infection%20fatality%20rate%20substantially%20decreased%20by%20approximately%2078.7%25

[5] https://www1.racgp.org.au/newsgp/clinical/vaccine-myocarditis-risk-reaches-1-in-10-000-for-a

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Malcolm Roberts drops bombshells in Senate after COVID Under Question inquiry

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The evidence continues to mount that these vaccines do not deserve the continuing provisional approval given to them by the TGA. Concerns about possible adverse side effects are too big to ignore any longer, especially after my COVID Under Question inquiry which you can watch by clicking here.

Transcript

As a servant to the people of Queensland and Australia, tonight I’m speaking on this parliament’s therapeutic response to COVID-19 and the horrific medical harm and loss of life in that response. Last week, leading Australian parliamentarians came together in an event I organised called COVID Under Question to present documented evidence and victim testimony proving a catastrophic failure of Australia’s regulatory framework. COVID vaccine injuries are hidden behind anonymous government data, while supposed COVID virus harm is splashed across prime time. The very least we can do for the victims of COVID vaccines is to say their names—victims like Caitlin Georgia Gotze, a healthy and vibrant 23-year-old studying at Griffith University to become a vet while working as a horse strapper. Caitlin dropped dead at work of a heart attack following a second Pfizer shot. Her death was recorded as asthma, a condition Caitlin had never had. Reginald Shearer, a formerly healthy fit and active man, quickly went downhill and passed away from effects that began after receiving the AstraZeneca vaccine. Daniel Perkins, a 36-year-old healthy father from Albion Park, died of a heart attack in his sleep following his second Pfizer injection. Douglas James Roberts died after taking AstraZeneca. His family are concerned that his GP didn’t warn him of the side-effects of the vaccine. In other words, no informed consent was obtained. Neurosurgeons at the Royal Brisbane and Women’s Hospital attributed his death to a stroke, despite no family history and a clean bill of health. They refused to report his death to the TGA—refused!

The Australian Health Practitioner Regulatory Agency, Ahpra, has been bullying medical practitioners into not reporting or even for talking about the harm they’re seeing. The TGA erased 98 per cent of the 800 vaccine deaths—98 per cent erased!—that physicians reported. The TGA did so without autopsy or suitable consideration of all the patient medical data. TGA, ATAGI and Ahpra are the three monkeys of the pharmaceutical industry: hear no evil, see no evil, speak no evil.

Section 22D(2) of the Therapeutic Goods Act 1989 requires the Secretary of the Department of Health to ensure the quality, safety and efficacy of the vaccines were satisfactorily established for each cohort for which the provision of approval is being granted. Data recently revealed in court papers in the United States clearly shows that vaccine harm was apparent in the clinical trials that Pfizer, BioNTech and others conducted. This information, if ATAGI had bothered to ask for it, should have resulted in a refusal of the application for provisional use. No data was provided to the secretary regarding individual test subjects—technically, anonymized patient clinical data. No independent analysis of the fundamental issues surrounding novel mRNA vaccines was conducted in Australia—none in Australia! Instead, the secretary took Pfizer, AstraZeneca and Moderna’s word for it.

I will say that again: the secretary took pharmaceutical companies’ word for the safety of their products. These are the same pharmaceutical companies that have been fined over and over for criminal behaviour. AstraZeneca got a US$355 million fine for fraud and, separately, a $550 million fine for making unfounded claims about efficacy. Pfizer got a $430 million fine for making unfounded claims about efficacy, and a $2.3 billion fine—that’s billion dollars—for making unfounded claims about efficacy and for paying kickbacks.

This is who the Liberal-Nationals, Labor and Greens—our very own pharmaceutical lobby—want to pay more money to. That’s not on the basis of extensive local testing and inquiry, it’s simply on the basis of taking pharmaceutical companies safety assurances. There’s no testing. It’s an assurance made easy by indemnity against any damage that the vaccines cause. What deceit! What criminal incompetence! The Labor Party and the Liberal-National Party have accepted $1 million each from the pharmaceutical establishment in this election cycle alone. Billions more are being set aside in this week’s budget to pay the pharmaceutical companies to keep the COVID-19 gravy train going. What great value this parliament provides for those electoral donations.

Mention should be made of the TGA’s decision to ban safe, fully approved and widely accepted alternatives to COVID-19 vaccines. This includes hydroxychloroquine and ivermectin; vitamins, minerals and natural antivirals; as well as proven messaging around healthy eating and lifestyles. The decision to ban proven, safe, affordable and accessible alternative treatments that are working around the world was taken to ensure the fastest and widest-possible adoption of the vaccines. The TGA’s own customers fund the TGA. That means pharmaceutical companies fund their own product’s approval. That fails the pub test. Where are the checks and balances? There are none.

The Australian Bureau of Statistics is culpable in this scandal and cover-up. The Australian Bureau of Statistics’ annual budget is $400 million. The most recent mortality data they provide is from November last year, four months behind. The most recent breakdown of mortality by cause and age is from 2020. The most recent data on live births is from 2020. Birth data used to be available six weeks after, not 15 months and counting. Are they hiding miscarriages?

At what point do we consider the actions of the TGA, ATAGI and the Australian Bureau of Statistics as interfering with the operation of the Senate? Peer-reviewed and soon-to-be-published data that must require the secretary to cancel the provisional approval of the vaccines has been released from outside of the government.

Let me review those quickly so the Senate fully understands the extent to which we have been misled. Firstly, freedom of information documents indicate the TGA has failed to assess the reproductive toxicology of the COVID vaccines. Freedom of information documents indicate the TGA has failed to assess the impact of microRNA sequences and related molecular genetic issues on the human body. Peer-reviewed and published in-vitro research shows gene based vaccine-generated spike proteins can migrate into human cell nuclei to disrupt DNA repair mechanisms. The TGA has dealt with this abysmally—murderously?

Vaccine-derived RNA can be reverse transcribed, leading to possible integration into the human genome, which the TGA denies, based only on pharmaceutical companies telling them to deny it. Internal Pfizer data released in February indicate they accept 1,272 different adverse vaccine events, including paralysis and death. German and US insurance actuarial data suggests the TGA’s database of adverse event notifications is underreporting side effects ninefold. Freedom of information documents from 2018 show the TGA keeps two databases of adverse event notifications: one internal, showing all reports of harm; and one public, showing only a part of those. This means vaccine harm is most likely significantly higher than reported.

Without honest and accurate data, the Senate has no way of deciding how much harm is too much harm. German pathologists describe pathological aggregates of spike proteins and lymphocyte infiltrations in inflamed organs in autopsies related to death post vaccination. In response, the TGA is failing to conduct autopsies on the 800 Australians the patients’ own doctors have reported as having died from the vaccines. What the hell is the TGA hiding?

Whistleblowers to the British Medical Journal provided reports of inadequacies, irregularities and possible fraudulent practices in the Pfizer vaccine trial—you know, the same trial for which the TGA took Pfizer’s word. From a modern immunological perspective, two frequent vaccines for respiratory viruses run the risk of desensitising the immune responses to the virus, and that leads to hypoimmunity and worse illness than without the immunisation. To put that simply: repeated vaccination is doing more harm than good.

These are the matters I sought today to refer to the Senate Select Committee on COVID-19 without success. I thank Senators Hanson, Abetz, Rennick and Antic for their support, integrity and courage. The truth is the Select Committee on COVID-19 has been running a protection racket for the pharmaceutical industry, and today’s vote proves it. This unprecedented betrayal of the Australian people must be referred immediately to a royal commission. To the Prime Minister, the health minister, the federal health department and all those in the Senate and the House of Representatives—all of you who have perpetrated this crime—I direct one question: how the hell do you expect to get away with it? We’re not going to let you get away with it. We won’t let you get away with it. We are coming for you. We have the stamina to hound you down and we damn well will.

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TGA fails duty of care to kids

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The TGA and the Morrison Government have failed to exercise duty of care towards vaccine approvals. Double Comirnaty vaccination has been approved for children despite evidence clearly showing a seven fold increase in serious harm between the first and second doses.

Transcript

[Malcolm] Thank you, Mr. President. My question is to the minister representing the Minister for Health, Senator Colbeck. The British Medical Journal has published an article revealing the company that conducted part of the phase three trials of Pfizer’s Comirnaty COVID vaccine. Covering 25,000 people, falsified data, unblinded patients, employed inadequately trained staff, and was slow to follow up on adverse events. Minister, the Morrison-Joyce government failed to conduct an Australian trial of the Pfizer vaccine. And instead, simply took Pfizer’s word for it. Was this a failure in your duty of care to the Australian people?

The minister representing the Minister of Health, Senator Colbeck.

[Richard] Thank you, Mr. President. Senator. I can’t agree with the statement that you make as a question Senator Roberts at all through, through you president. The Australian government took, undertook a comprehensive assessment of each and every vaccine that is being used in this country to ensure Australians had the confidence. That we had a safe and efficacious vaccine for utilisation in the pandemic. And Mr. President, I think the results speak for themselves. If you look at the circumstances in respect of what’s occurred in aged care this year, compared to last year, the impact is profound. Mr. President, it is very clear that we took all steps to ensure that the vaccines that are being used in this country was safe and that they worked. We, we took evidence and advice, yes, from the companies we received the data that they used in their trials, appropriately. But we also had the advantage of being able to use data from other jurisdictions around the world. And we’ve remained in close contact with those agencies that consider vaccines to ensure that they are safe to use. Mr. President. Can I say to all Australians who are still contemplating whether or not they should get a vaccine. Please be assured that our public health system and our authorities, the Therapeutic Goods Administration, recognised as one of the best in the world, has done the, the, the, yes Senator Reynolds, amazing work. To ensure that we have access, Australians have access, anyone living in this country, wants a vaccine has access to a safe and efficacious vaccine

Minister, your time has expired. Senator Roberts, a supplementary question.

Thank you. Prior to the TGA’s approval of Comirnaty vaccine, Steve Anderson, the Director of the US Centre for Biologics Evaluation and Research released data detailing potential Comirnaty adverse outcomes, including Guillain-Barré syndrome, acute myocarditis, auto immune disease, and death. This is exactly what’s happened. In approving Pfizer’s Comirnaty injections, did the TGA fail in it’s duty of care to the Australian people?

Minister.

Thank you, Mr. President. No, it did not. I couldn’t be any firmer than that. And as I indicated in my answer to the primary question, the Therapeutic Goods Administration has considered all data in relation to the vaccine. And in fact, it continues to monitor the data in relation to the vaccines. We’ve, we’ve been extremely open with respect to that. We’ve published reporting on the outcomes of the vaccination programme here in Australia. We’ve published data in relation to adverse reactions, to the vaccines of all types. Mr. President. So I reject any assertion that the TGA has failed in its duty at all. No, it has not. I could not be any firmer, President. We have one of the best and we should be proud of the fact that we have one of the best therapeutic goods assessment, organisations in the world.

Your time has expired. Senator Roberts, a second supplementary question.

Thank you. Latest data from America’s CDC indicates that children aged 12 to 17 are likely to experience mmyocarditis and related conditions at the rate of 9.5 cases per million vaccinations. Yet after the second vaccination, that rate rises sevenfold from 9.5 to 66.7. In approving two doses of Pfizer Comirnaty for our children without testing, are the Minister for Health Greg Hunt and Professor Skerritt at the TGA, risking our children’s lives, health and future.

Minister

There’s a very simple answer to that question, President, it’s no. As I’ve said in my previous answer, the TGA continues to monitor all of the data, not just from Australia, but from around the world, in relation to the impact and the utilisation of the vaccines. Particularly those that we have to be administered here in Australia. We continue to monitor all of the data so that we have the most up-to-date information and that we can continue to assure Australians that the vaccines that they are taking are both safe and efficacious. And all of the data and the advice, continues to demonstrate that Mr. President. Are there contrary indications in relation to the vaccines? Yes, there are. We published the data so that we’re open with that. But we need to make sure that Australians have confidence that the vaccines we have access to a safe and efficacious.

Time has expired.

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Health Minister stops smokers quitting

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Thousands of Australians, desperate to quit smoking, will find it almost impossible to purchase nicotine for vaping thanks to Minister Hunt’s capricious decision to ban nicotine imports.

When parliament resumes in August One Nation will move to disallow the new regulations and propose new rules for importing nicotine until local options are available.

“Instead of tackling the issue of illegal importation of nicotine at the border, Minister Hunt imposes draconian regulations that punish vaping users trying to give up smoking,” stated Senator Roberts.

British and New Zealand Governments widely support vaping as one of the most effective ways to quit smoking, however Australia has seen an increase in illegal nicotine supply, likely due to poor Border Force policing.

“This is a lazy decision on behalf of the Minister with zero consultation with industry, users and the medical profession,” Senator Roberts said.

The current laws require a doctor’s prescription prior to importation with proof given to Border Force to allow imports of nicotine for vaping based on prescriptions.

“The increase in illegal nicotine is Border Force not doing their job and not enforcing script-only imports,” said Senator Roberts.

A company needs to spend millions of dollars for research to get nicotine through the TGA process before there is any hope that an Australian chemist can sell it.

Senator Roberts added, “The Government needs to urgently fund the TGA approval process so Australians can buy nicotine for vaping without having to import it. “One Nation supports the use of nicotine for vaping to quit smoking and thousands of Australians can testify to its effectiveness.”

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